Germany · Paul-Ehrlich-Institut · Vaccines
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
2 requirements
Application fee
€7,500
2026
Each batch of a serum, vaccine or allergen may be sold in Germany only after the Paul-Ehrlich-Institut releases it, in addition to the marketing authorisation. The decision is due within two months after the batch sample arrives. A batch is also released when another EU member state's authority found, after laboratory testing, that it meets the requirements. The institute can exempt products whose manufacturing and control methods are mature. Every batch of sera, vaccines, allergens and blood products covered by official batch release, before sale in Germany.
The batch release, vaccine with more than five antigens is €7,500 for 2026.
1. Send batch documents and samples; 2. Testing and release decision (61 days); 3. Batch may be sold.
Yes. It relies on approvals from European Union (recognition).
Outcome: A national batch release notice that allows the batch to be placed on the German market.
Legal basis: Arzneimittelgesetz (AMG) § 32
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 61 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Decisionlaw. About 2 months after the batch sample arrives. This is an official target in the law, not an actual review time. | 61 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Batch release, vaccine with more than five antigensOther · 2026 | €7,500 |
| Batch release, vaccine with two to five antigensOther · 2026 | €4,500 |
| Batch release, vaccine with one antigenOther · 2026 | €2,900 |
| Batch release, immunoglobulins and blood productsOther · 2026 | €1,000 |
| Batch release based on recognition of an EU certificate, without new testingOther · 2026 | €170 |
Other routes in Germany: Decentralised procedure with Germany as reference member state, Mutual recognition procedure (Germany as reference or concerned member state), National authorisation of vaccines, sera, blood products and allergens (Paul-Ehrlich-Institut), Approval of tissue preparations, Compassionate use programme. See all routes on the Germany page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (12 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.